Marginum Oy
Active in EUDAMEDFinlandfrom SRN EUDAMED SRN FI-MF-000030256
- Devices
- 1
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
What Marginum Oy makes
Marginum Oy manufactures fluorescence-based tissue detection systems, including the HIVEN device, designed for intraoperative surgical monitoring. These systems utilize optical imaging to enhance the identification and differentiation of tissue types during procedures, supporting precision in surgical environments.
The company’s products fall under EU Class IIb medical devices and are registered in the EU’s eudamed database. Marginum Oy is based in Finland and adheres to relevant EU regulatory requirements for these device classifications.
Catalogue
Hiven Ref 06429810994004
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- FI-MF-000030256
- EU VAT number
- FI31676548
- EUDAMED status
- Active
- EUDAMED registered name
- Marginum Oy
- Registered address
- 6-8, Hermiankatu, 33720, TAMPERE, Finland
- Website
- www.marginum.com
- linkedin.com/company/marginum
- facebook.com/marginum
- [email protected]
- Phone
- +358 40 5797890
- PRRC contact
- Teemu Tapio
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 16 Sep 2027
SGS FIMKO OY 0598 1 certificate
- FI25/00000050 Expiring
Quality management system EU MDR
- Issued
- 16 Sep 2025
- Expires
- 16 Sep 2027
- Valid from
- 17 Sep 2025
From the company website
Marginum is a medical technology company developing fluorescence-based tissue detection systems. We use data-driven solutions to improve surgical tissue monitoring.
Frequently asked questions
How many devices does Marginum Oy have in the registry?
The registry currently lists 1 device for Marginum Oy. Devices recorded under merged duplicate company entries are counted once.
Which registries list Marginum Oy's devices?
Among its 1 most recently registered device, Marginum Oy has devices listed in EUDAMED (1 device).
What risk classes do Marginum Oy's devices fall under?
Among its 1 most recently registered device, the classes recorded for Marginum Oy's devices are Class IIb. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Marginum Oy?
EUDAMED lists 1 certificate for Marginum Oy (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 16 Sep 2025.
What are the newest devices from Marginum Oy in the registry?
The most recently registered devices listed for Marginum Oy include HIVEN.